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Director of Biostatistics

San Diego, CA

Order: 53735

Experience and Skills

Qualifications:

  • The Director, Biostatistics has a PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with 10 years of relevant work experience OR a Masters degree in Statistics or Biostatistics or a related health science field, and 11-12 years of biostatistical experience in the clinical trials or health research environment.

  • Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics

  • Familiarity with pharamcokinetic/pharmacodynamic data

  • Experience supporting publication of analysis results (e.g. abstracts, posters, manuscripts)

  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.

  • Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies.

  • eCTD BLA/NDA experience as well as past interaction with FDA and/or interaction with EMA/CPMP and preparation of MAA

  • Demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership of staff.

REQUIRED KNOWLEDGE AND ABILITIES:

  • Knowledge of CDISC requirements for SDTM and ADaM

  • Exceptional interpersonal skills and problem-solving capabilities.

  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.

  • Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required.

  • Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines.

  • Requires understanding of the company’s products, the competition, and the pharmaceutical industry in general

  • Maintains current awareness of new drug developments in the business.